Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:
- Does the intervention increase the number of new leprosy cases detected compared to standard care?
Participants will:
Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multifaceted intervention | Experimental | Implementation of active-case finding strategies |
|
| Standard of care | No Intervention | Routine screening |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementing active-case finding strategies | Other | Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire). |
| Measure | Description | Time Frame |
|---|---|---|
| New cases of leprosy | Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants. | From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Leprosy Suspicion Questionnaire usefulness | Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test | From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months. |
Not provided
Inclusion Criteria:
(I) Municipalities
(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.
(III) Participants
• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.
Exclusion Criteria:
(I) Municipalities
(II) Primary Health Units
(III) Participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian A Vernal, MD, PhD | Contact | +61 488 062 931 | vernal.carranza@gmail.com | |
| Katia C Braz | Contact | +55 11 99616 5496 | katia.braz@haoc.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Rosa C Lucchetta, PhD | Hospital Alemão Oswaldo Cruz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Alemão Oswaldo Cruz | Recruiting | São Paulo | 01327-001 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007918 | Leprosy |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
Cluster stepped-wedge
Not provided
Not provided
Data analyst (statistician)
Not provided
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |